非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323892243892193894253887093889683891090.08
211.323943623972393958000.52
单位质量响应值RSD%判断
34373.5934964.661.21数据可信
供试品溶液-BXK0LE1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154815-5481514.23114.9812.9914.2314.9812.99
247984-4798412.45712.46
351957-5195713.48913.49
463067-6306716.37316.37
560325-6032515.66115.66
668161-6816117.69617.70
10min1128703-12870333.41336.507.8933.4436.527.89
2129727-12972733.67933.70
3139160-13916036.12836.15
4148248-14824838.48838.51
5139934-13993436.32936.36
6157746-15774640.95340.98
15min1176850-17685045.91351.027.1845.9951.117.18
2184596-18459647.92448.00
3202701-20270152.62452.71
4202284-20228452.51652.61
5196360-19636050.97851.06
6216356-21635656.16956.27
20min1208662-20866254.17260.447.0654.3360.627.05
2219320-21932056.93957.10
3242513-24251362.96063.13
4238312-23831261.87062.05
5233935-23393560.73360.90
6254177-25417765.98866.18
30min1253068-25306865.70072.546.5465.9572.816.54
2262860-26286068.24368.49
3293985-29398576.32376.60
4284061-28406173.74774.03
5281614-28161473.11173.38
6300805-30080578.09478.40
45min1293104-29310476.09482.615.1676.4583.005.16
2304578-30457879.07379.44
3330939-33093985.91786.32
4320431-32043183.18983.59
5323742-32374284.04984.44
6336342-33634287.32087.75
60min1315448-31544881.89587.754.5382.3888.284.54
2325577-32557784.52585.02
3348147-34814790.38490.93
4336407-33640787.33787.88
5346183-34618389.87590.41
6356341-35634192.51293.09
极限1341049-34104988.54292.843.1689.1693.523.18
2348319-34831990.42991.07
3362337-36233794.06894.76
4357036-35703692.69293.38
5365558-36555894.90595.59
6371447-37144796.43497.16
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.323836983837783838653838953840253838520.04
211.323909333912263910800.06
单位质量响应值RSD%判断
33909.1934547.701.32数据可信
供试品溶液-BXK0LE1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148188-4818812.67213.0315.1112.6713.0215.11
239225-3922510.31510.31
360365-6036515.87415.87
455763-5576314.66414.66
547541-4754112.50112.50
646124-4612412.12912.13
10min1119067-11906731.31032.7210.3031.3332.7410.29
2109599-10959928.82028.84
3128162-12816233.70233.73
4140356-14035636.90836.93
5112317-11231729.53529.56
6136991-13699136.02336.04
15min1192188-19218850.53848.7910.6750.6148.8710.66
2169659-16965944.61444.68
3177130-17713046.57846.66
4201417-20141752.96553.05
5160625-16062542.23842.31
6212313-21231355.83055.91
20min1233128-23312861.30459.527.4361.4659.687.43
2212550-21255055.89356.03
3215378-21537856.63656.80
4236844-23684462.28162.46
5208668-20866854.87255.01
6251507-25150766.13766.31
30min1277646-27764673.01072.073.9973.2772.334.00
2264368-26436869.51969.75
3264140-26414069.45969.71
4276584-27658472.73173.01
5268799-26879970.68470.92
6292939-29293977.03277.32
45min1309366-30936681.35281.431.9281.7381.811.93
2306060-30606080.48280.83
3302271-30227179.48679.86
4310956-31095681.77082.17
5309425-30942581.36781.72
6319956-31995684.13684.55
60min1327868-32786886.21786.510.8686.7387.020.87
2326341-32634185.81586.30
3326401-32640185.83186.33
4328679-32867986.43086.97
5331137-33113787.07687.56
6333437-33343787.68188.23
极限1356882-35688293.84691.931.2294.5192.591.22
2345101-34510190.74891.37
3347520-34752091.38592.03
4346604-34660491.14491.82
5351503-35150392.43293.06
6349996-34999692.03692.73
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